Nuvation Bio Announces Acquisition of Japan Rights to Safusidenib from Daiichi Sankyo

Nuvation Bio (NYSE: NUVB) amended its safusidenib license with Daiichi Sankyo to acquire Japan rights, securing exclusive global development and commercialization rights for the investigational IDH1 inhibitor.

Rhea-AI Summary

Nuvation Bio (NYSE: NUVB) amended its safusidenib license with Daiichi Sankyo to acquire Japan rights, securing exclusive global development and commercialization rights for the investigational IDH1 inhibitor. The deal enables expansion of the Phase 3 SIGMA study into Japan and grants rights to prior and future clinical data and publications.

Safusidenib is an oral, brain-penetrant mutant IDH1 inhibitor with encouraging Phase 1/2 activity in IDH1-mutant glioma; Phase 2 Japan data include a median follow-up of over five years for 12 patients still on treatment.

Positive

• Exclusive global rights to safusidenib acquired
• Enables expansion of pivotal Phase 3 SIGMA study into Japan
• Ownership of all past and future clinical data and publication rights
• Phase 2 Japan dataset includes >5-year median follow-up for 12 patients

Negative

• Key clinical evidence remains limited: Phase 2 included only 27 patients
• Phase 1 Japan study had 47 participants, a small sample for broad inference
• Safusidenib is still investigational with no regulatory approval yet

Argus Apr 1 session

+5.13% close to close Open Argus

Details

News Market Reaction – NUVB

On Apr 1, the day this news came out, NUVB closed 5.13% above the previous close.

Data tracked by StockTitan Argus for the Apr 1 session.

Key Figures

Phase 1 sample size: 47 participants Phase 2 sample size: 27 patients Patients remaining on treatment: 12 patients +5 more

Phase 1 sample size

47 participants

Phase 1 study in Japan for recurrent or progressive IDH1-mutant glioma

Phase 2 sample size

27 patients

Phase 2 study in Japan, grade 2 IDH1-mutant glioma

Patients remaining on treatment

12 patients

As of February 2026 in Japan Phase 2 safusidenib study

Median follow-up

Over 5 years

Japan Phase 2 safusidenib study as of February 2026

Data cut-off date

March 10, 2023

Japan Phase 2 safusidenib data published in Neuro-Oncology

Publication date

November 2025

Neuro-Oncology online publication of Japan Phase 2 safusidenib data

Price reaction

5.93%

24-hour move on acquisition of Japan rights to safusidenib

52-week range

$1.54–$9.75

NUVB 52-week low and high before this news

Previous Acquisition Reports

1 past event · Latest: Apr 10

Same Type 1 event

1. Apr 10

   Pipeline acquisition

   24h Move

   +3.3%

   Completion of AnHeart Therapeutics acquisition, expanding Nuvation’s oncology portfolio.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 3, phase 2, phase 1, progression-free survival, +2 more

6 terms

phase 3 medical

"ongoing Phase 3 SIGMA study for the maintenance treatment of patients"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

phase 2 medical

"Data from a Phase 2 study in Japan of safusidenib in 27 patients"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

phase 1 medical

"In the Phase 1 study in Japan of 47 participants with recurrent"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

progression-free survival medical

"including durable responses and prolonged progression-free survival that show tumor"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

idh1-mutant glioma medical

"safusidenib results in IDH1-mutant glioma. Safusidenib is a novel"

A disease in which a brain tumor (glioma) carries a specific change in the IDH1 gene that alters the tumor’s metabolism and behavior. That mutation often defines a distinct group of patients with different prognosis and treatment responses, so it matters to investors because it creates a targeted patient population for drugs, diagnostics and clinical trials—think of it like a unique lock that only certain therapies can open.

astrocytoma medical

"for the maintenance treatment of patients with IDH1-mutant astrocytoma who have"

A growth of abnormal cells in the brain that arises from astrocytes, the star-shaped cells that support neurons and maintain the brain’s environment. Investors watch astrocytoma because it drives demand for diagnostics, treatments, and clinical trials; news about successful drugs, trial results, or regulatory approvals can materially affect the finances of healthcare companies, similar to how a breakthrough fixes a major bottleneck in an industry.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

With acquisition of Japan rights, Nuvation Bio now has global development and commercialization rights for safusidenib

Agreement provides Nuvation Bio ownership of global clinical development program, inclusive of clinical trials, past and current data generation, and future publications

NEW YORK, April 1, 2026 /PRNewswire/ -- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced the company has amended its existing exclusive license agreement for safusidenib with Daiichi Sankyo (TSE :4568) to include Japan rights, effectively securing exclusive global development and commercialization rights of the investigational medicine. The agreement, as amended, enables Nuvation Bio to expand its ongoing pivotal SIGMA study of safusidenib into Japan, and provides rights to all previously generated and future data to support further publication of safusidenib results in IDH1-mutant glioma.

Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1 that is currently being evaluated in the ongoing Phase 3 SIGMA study for the maintenance treatment of patients with IDH1-mutant astrocytoma who have high-risk features following standard-of-care.

In Phase 1 and Phase 2 single arm studies, safusidenib has shown encouraging efficacy signals across all IDH1-mutant glioma grades and treatment lines, including durable responses and prolonged progression-free survival that show tumor shrinkage and disease control. In the Phase 1 study in Japan of 47 participants with recurrent or progressive IDH1-mutant glioma with enhancing (predominantly high-grade) and non-enhancing (predominantly low-grade) tumors, safusidenib showed clinical activity in both populations. Data from a Phase 2 study in Japan of safusidenib in 27 patients with chemotherapy- and radiotherapy-naïve grade 2 IDH1-mutant glioma was published online in the November 2025 issue of Neuro-Oncology. The data published reflected a March 10, 2023 data cut-off. As of February 2026, 12 patients in the study remain on treatment with safusidenib with a median follow-up of over 5 years. Nuvation Bio plans to present longer-term data from the Phase 2 study at a future medical meeting.

"We believe safusidenib has immense potential to address significant patient needs in IDH1-mutant glioma, and our current development plan focuses on patient groups with limited or no FDA-approved targeted treatment options. We are thrilled to now have the exclusive global development and commercialization rights to explore this investigational medicine's potential across these devastating brain tumors," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "With this agreement now final, we plan to expand the pivotal Phase 3 SIGMA study into Japan, continue to advance the robust global development of safusidenib, and pursue presentation and publication of longer-term data from the Phase 2 study to ensure the scientific community is up to date on these findings."

"The invention of new medicines is at the core of what we do at Daiichi Sankyo and safusidenib is a strong example of our expertise in science and technology," said Yuki Abe, Ph.D., Head of R&D Division in Japan and Head of Research, Daiichi Sankyo. "We continuously evaluate the best approach to accelerate the delivery of promising medicines to patients and we are confident that Nuvation Bio will carry this program forward, utilizing their strong expertise in clinical development and commercialization to explore the full potential of safusidenib for patients with IDH1-mutant glioma."

About IDH1-Mutant Glioma
Gliomas are the most common type of brain cancer in adults worldwide. In the U.S., nearly 2,500 people are diagnosed with IDH1-mutant gliomas each year, of which more than 95% harbor a mutation in the IDH1 gene. Most patients are diagnosed in their 30s and 40s. While patients with IDH1 mutations generally have longer survival times than those with wild-type IDH1, gliomas are not currently curable and prognosis worsens for those with high-risk features, including high grade tumors.

About Safusidenib
Safusidenib is a novel, oral, potent, brain-penetrant, selective inhibitor of mutant IDH1. In Phase 1 and Phase 2 clinical studies, safusidenib delayed disease progression and provided durable responses across grades and risk groups with a favorable risk-benefit profile.

About the SIGMA (G203) Study
SIGMA is a pivotal Phase 3 study that will evaluate safusidenib compared to placebo as a maintenance therapy after standard-of-care in IDH1-mutant astrocytoma with high-risk features. The pivotal portion of the study will enroll approximately 300 patients. Data is anticipated to be available in 2029.

A separate, exploratory, non-pivotal cohort will evaluate safusidenib in participants with grade 3 IDH1-mutant oligodendroglioma who have not yet received chemotherapy or radiotherapy. The primary endpoint is objective response rate. This cohort is expected to enroll approximately 40 patients. Data is anticipated to be available in 2027.

About Nuvation Bio
Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment with the goal of developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes taletrectinib (IBTROZI^®), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor; and an innovative drug-drug conjugate (DDC) program.

Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit www.nuvationbio.com or follow the company on LinkedIn and X (@nuvationbioinc). 

Forward-Looking Statements
Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding safusidenib's therapeutic potential, development plans, and plans to present new data. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and commercialization, and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; physician and patient behavior; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-K filed with the SEC on March 2, 2026 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

Media and Investor Contacts

Nuvation Bio Investor Contact
JR DeVita
ir@nuvationbio.com

Nuvation Bio Media Contact
Kaitlyn Nealy
media@nuvationbio.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/nuvation-bio-announces-acquisition-of-japan-rights-to-safusidenib-from-daiichi-sankyo-302730492.html

SOURCE Nuvation Bio Inc.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did NUVB announce on April 1, 2026 about safusidenib Japan rights?

NUVB acquired exclusive Japan rights, giving it global development and commercialization control. According to the company, the amended agreement permits expansion of the Phase 3 SIGMA study into Japan and control of prior and future clinical data.

How does the NUVB-Daiichi Sankyo amendment affect the Phase 3 SIGMA study?

The amendment enables SIGMA to expand enrollment into Japan, broadening geographic reach and patient access. According to the company, this supports global development and alignment of data for regulatory and publication purposes.

What clinical evidence of safusidenib in Japan did NUVB cite in the announcement?

NUVB cited Phase 1 data from 47 participants and a Phase 2 study of 27 patients in Japan. According to the company, Phase 2 shows durable responses and over 5 years median follow-up for 12 patients still on treatment.

Will NUVB be able to publish previous safusidenib clinical data after the deal?

Yes. The agreement grants NUVB rights to previously generated and future safusidenib data for publication. According to the company, this allows dissemination of longer-term Phase 2 results at medical meetings and in journals.

Does the April 1, 2026 agreement with Daiichi Sankyo give NUVB commercialization rights for safusidenib?

Yes. NUVB now holds exclusive global development and commercialization rights for safusidenib, including Japan. According to the company, it will pursue commercial development pending clinical and regulatory progress.

What are the near-term data presentation plans NUVB announced for safusidenib?

NUVB plans to present longer-term Phase 2 data at a future medical meeting. According to the company, these presentations will update the scientific community on extended follow-up and clinical activity in IDH1-mutant glioma.